The purpose of this study is to investigate how quickly and to what extent ONO-5788 is absorbed and how ONO5788 is eliminated from the body. . ONO-5788 will be labelled with 14-Carbon (14C) and is thus radioactive. In this way ONO-5788 can be traced…
ID
Source
Brief title
Condition
- Hypothalamus and pituitary gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part 1
Absolute BA of ONO-5788 in plasma.
Part 2
Total recovery of radioactivity in urine and faeces following a single oral
dose of [14C]-ONO-5788 (expressed as a percentage of the total radioactive dose
administered).
Secondary outcome
Part 1 and 2
PK parameters of total drug-related material (radioactivity, ONO-5788, and
ONO-ST1-641) in blood and plasma (Table 4).
Blood/plasma ratio of total drug-related material (radioactivity, ONO-5788, and
ONO-ST1-641).
Safety and tolerability parameters including collection of adverse events
(AEs), physical examinations, vital signs, 12-lead electrocardiograms (ECGs),
and laboratory evaluations.
Part 2
Characterization and identification of [14C]-ONO-5788 metabolites in plasma,
urine and faeces.
PK parameters of total radioactivity in urine.
Background summary
ONO-5788 is a new compound that may eventually be used for the treatment of
acromegaly. Acromegaly is a disorder that results from excess production of
growth hormone (GH) by the pituitary gland, a gland near the brain involved in
the regulation of several hormones. In acromegaly, excess production of GH is
caused by an adenoma (a benign tumor, i.e., not cancer) near the pituitary
gland. If this happens before or during puberty, it can result in extreme
growth. If this happens after puberty, the growth is restricted to the hands
and feet and sometimes the forehead, jaw, nose, arms and legs. Treatments for
acromegaly include somatostatin analogues (SSAs), compounds that mimic the
hormone somatostatin which blocks production of GH in the body. Though SSAs
work well in acromegaly, they require frequent injections which can be painful.
ONO-5788 is an SSA which can be administered orally, offering a more convenient
solution for patients.
Study objective
The purpose of this study is to investigate how quickly and to what extent
ONO-5788 is absorbed and how ONO5788 is eliminated from the body. . ONO-5788
will be labelled with 14-Carbon (14C) and is thus radioactive. In this way
ONO-5788 can be traced in blood, urine, and feces to determine how it is
eliminated from the body.
Study design
The actual study will consist of 1 period during which the subject will stay in
the research center for 12 days (11 nights). In addition, the subject will be
called between Day 14 and 16. The subject will then be asked about your
wellbeing.
Day 1 is the day of administration of the study compound. The subject is
expected at the research center at 14:00 h in the afternoon prior to the day of
administration of the study compound. He will leave the research center on Day
11 of the study.
However, if the radioactivity found in the urine and feces is higher than the
pre-defined levels on Day 11, the subject will return to the research center
for 24-hour collection of urine and feces on Day 14-15, Day 21-22, Day 28-29,
and Day 42-43. For these collection intervals, the subject is expected in the
research center in the morning of Day 14, 21, 28, and Day 42, and he can leave
after the 24-hour collection interval (Day 15, 22, 29, and Day 43). He will
only need to return until the radioactivity levels fall below the pre-defined
levels.
Intervention
Part 1: ONO-5788 will be given as an oral capsule with 240 milliliters (mL) of
water. Two hours and 15 minutes after intake of the capsule, an intravenous
infusion of 0.1 mg [14C]-ONO-5788 will start. This infusion will last 15
minutes.
Part 2: [14C]-ONO-5788 will be given as a drink of 50 milliliters (mL). After
administration of the study compound, the vial will be rinsed with 50 mL of the
vehicle (the solution without the study compound) and 50 mL of water, which the
subject will also be required to drink. Thereafter the subject is also required
to drink an additional amount of 100 mL of water.
The subject will receive 10 mg ONO-5788 containing 4.1 MBq of radioactivity.
Study burden and risks
See section E.9
High Holborn 71
London WC1V 6EA
GB
High Holborn 71
London WC1V 6EA
GB
Listed location countries
Age
Inclusion criteria
1. The subject is willing and able to provide written informed consent.
2. Male subjects aged 21 to 65 inclusive at the time of signing the informed consent form.
3. The subject is able to communicate with the Investigator and the site staff.
4. A subject is eligible to participate if he is not trying to father a child, is willing to use one of the contraception methods listed in Section 5.3 and agrees not to donate sperm, from Day 1 of the study until 90 days after dosing.
5. The subject has a body mass index of 18.5 to 30.0 kg/m2, inclusive at screening.
Exclusion criteria
1. The Investigator deems the subject unsuitable for the study as a result of the screening examinations.
2. The subject is an employee of the Sponsor or contract research organization.
3. The subject has, or has a history of, any significant disease or disorder that would increase the risk for the subject if they were enrolled in the study or would affect study procedures or outcomes such as:
a. Gallstones, cholangitis, and/or cholecystitis;
b. Pancreatitis;
c. Hypothyroidism;
d. Known diabetes mellitus type 1 or type 2;
e. Hypocalcaemia or hypokalaemia;
f. Hypoglycaemia or hyperglycaemia or fasting blood glucose outside normal local range;
g. Thrombocytopenia or other clinically significant haematologic abnormalities;
h. Inflammatory bowel disease, irritable bowel syndrome, or abdominal surgery (with the exception of appendectomy);
i. Known vitamin B12 deficiency.
4. The subject has a positive, pre-study, hepatitis B, hepatitis C or human immunodeficiency virus test.
5. The subject has clinically significant serum electrolyte (sodium, potassium, chloride, bicarbonate) abnormalities at screening or admission, in the estimation and clinical judgment of the Investigator or designee.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-004270-94-NL |
| CCMO | NL68467.056.18 |